MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TESTOSTERONE II ASSAY; TESTOSTERONE ASSAY

Catalog Number 08946370190

Device Problems Incorrect Measurement (1383); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

Event Type  malfunction  

Event Description

We received an allegation about discrepant results of 1 patient's serum sample tested with elecsys testosterone g2 (testosterone ii) assay on a cobas e801 immunoassay analyzer when compared to liquid chromatography mass spectrometry (lc/ms) methodology.Initial result: 4.33 nmol/l.1st repeat result: 4.38 nmol/l (repeated on e801).2nd repeat result: 0.3 nmol/l (tested with lc/ms - referral laboratory).3rd repeat result: 0.39 nmol/l (repeated with lc/ms).4th repeat result: 1.01 nmol/l (tested on beckman coulter).

Manufacturer Narrative

The testosterone reagent expiration date was not provided.The cobas e801 module serial number was (b)(6).The calibration and qc prior to the event were acceptable.The alarm trace showed multiple alarms including sample clot detection alarm, abnormal aspiration (sample probe) alarms, and incubation water short alarm.The sample was requested for investigation.The investigation is ongoing.

Manufacturer Narrative

Section d4 was updated.The sample was not provided for investigation.Calibration was acceptable.The alarm trace showed multiple alarms including a sample foam detection alarm.A general reagent issue can be excluded because qc was acceptable prior to the event.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TESTOSTERONE II ASSAY
• Type of Device: TESTOSTERONE ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18336075
• MDR Text Key: 330704922
• Report Number: 1823260-2023-04042
• Device Sequence Number: 1
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K211685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08946370190
• Device Lot Number: 689384
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MIRTAZAPINE; PROPRANOLOL
• Patient Age: 24 YR
• Patient Sex: Female